MAUDE Adverse Event Report: HOLOGIC, INC EVIVA_0913-20; INSTRUMENT, BIOPSY

Model Number EVIVA_0913-20

Device Problems Failure to Obtain Sample (2533); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.

Event Description

It was reported that during an eviva procedure on (b)(6) 2024 , the needle was inside the breast and the customer could not take the sample.The physician reported that air was leaking from the needle.The biopsy could not be completed due to the physician no longer having functional needles in stock.The patient was rescheduled for a new procedure.No other information is available.

• Brand Name: EVIVA_0913-20
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free park zone b24; san jose 20102
• MDR Report Key: 19202042
• MDR Text Key: 341274473
• Report Number: 1222780-2024-00164
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045504974
• UDI-Public: (01)15420045504974(17)260111(10)E24A12RB
• Combination Product (y/n): N
• PMA/PMN Number: K180233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVIVA_0913-20
• Device Catalogue Number: EVIVA_0913-20
• Device Lot Number: E24A12RB
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/12/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other